Last updated: 06/06/2024 02:40:26
Protocol for evidence synthesis to assess comparative efficacy of triple therapies versus other combination treatments for COPD in adult patients
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Protocol for evidence synthesis to assess comparative efficacy of triple therapies versus other combination treatments for COPD in adult patients
Trial description: Triple combination therapy is increasingly being used in COPD management. One such triple combination is Fluticasone furoate/Umeclidinium/Vilanterol (FF/UMEC/VI). But currently, FF/UMEC/VI has no direct evidence compared with other relevant triple therapy combinations. Therefore the aim of this retrospective study is to explain the evidence synthesis to assess comparative efficacy of triple therapies versus other combination treatments for COPD in adult subjects. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines will be used to identify published, randomized controlled clinical trials (RCTs) comparing selected therapies in subjects with COPD. A systematic literature review including these studies will be then used to perform a frequentist indirect treatment comparison and a Bayesian network meta-analysis.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Change from Baseline in trough Forced Expiratory Volume in 1 second (FEV1) at week 12
Timeframe: Baseline Up to 12 weeks
Secondary outcomes:
Change from Baseline in trough FEV1 at week 24
Timeframe: Baseline Up to 24 weeks
Change from Baseline in St. George’s Respiratory Questionnaire (SGRQ) total score
Timeframe: Baseline up to 24 weeks
Change from Baseline in Transitional dyspnea index (TDI) focal score
Timeframe: Baseline up to 24 weeks
Decrease in mean number of puffs used per day of the rescue medication
Timeframe: Baseline up to 24 weeks
Interventions:
Drug: LABA/ICS + placebo therapy
Drug: Other LABA/ICS plus LAMA therapy
Drug: Triple combination therapy: FF/UMEC/VI
Drug: LAMA/LABA + placebo therapy
Enrollment:
1
Observational study model:
Other
Primary completion date:
2023-01-05
Time perspective:
Other
Clinical publications:
Afisi S. Ismaila, Katrin Haeussler, Alexandrosz Czira, Ji-Hee Youn, Mia Malmenäs, Nancy Risebrough, Jatin Agarwal, Maria Nassim, Raj Sharma, Chris Compton, Claus F. Vogelmeier, MeiLan Han, David M. G. Halpin. Fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy compared with other therapies for the treatment of COPD: a network meta-analysis. Adv Ther. 2022;
DOI:10.1007/s12325-022-02231-0
PMID: NULL
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol/umeclidinium bromide, umeclidinium bromide, vilanterol
Collaborators
Not applicable
Study date(s)
January 2017 to May 2023
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Not applicable
- Only RCTs, irrespective of blinding status, Phase III or Phase IV, parallel-group with minimum study duration of 8 weeks.
- Studies reporting outcomes of interest for ICS/LABA + LAMA combination therapies compared to each other or to LAMA/LABA + placebo, LABA/ICS + placebo.
- For abstract selection: Cross-over studies, if cross over before 8 weeks in each arm, Post-hoc or retrospective analyses, Cost-effectiveness analyses, Observational studies, Reviews or meta-analyses, Methodology studies or protocols, N of 1 trials (sample size of 1 subject). Studies lasting less than 8 weeks. Studies which are not in English or German language. Studies with conference abstracts before 2009.
- For full-text selection: Studies where subjects were required to spend time in a sleep laboratory.
Inclusion and exclusion criteria
Inclusion criteria:
- Only RCTs, irrespective of blinding status, Phase III or Phase IV, parallel-group with minimum study duration of 8 weeks.
- Studies reporting outcomes of interest for ICS/LABA + LAMA combination therapies compared to each other or to LAMA/LABA + placebo, LABA/ICS + placebo.
- Subjects with COPD as defined by Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines (i.e. airflow limitation that is not fully reversible).
- Studies that include asthma and COPD subjects and report data for COPD subjects separately.
- Studies that include adults and children and report data for adults separately.
- For Full text selection : Studies that report results for at least one of these outcomes at 8-16 weeks or 20-28 weeks (for all treatments): Trough FEV1, SGRQ, TDI, rescue medication use.
Exclusion criteria:
- For abstract selection: Cross-over studies, if cross over before 8 weeks in each arm, Post-hoc or retrospective analyses, Cost-effectiveness analyses, Observational studies, Reviews or meta-analyses, Methodology studies or protocols, N of 1 trials (sample size of 1 subject). Studies lasting less than 8 weeks. Studies which are not in English or German language. Studies with conference abstracts before 2009.
- For full-text selection: Studies where subjects were required to spend time in a sleep laboratory.
- Studies with following interventions: Beta-agonists (Bambuterol; Fonoterol; Tulobuterol), Short-acting anticholinergics (Ipratropium; Oxitropium), Methylxanthines (Theophylline), leukotriene receptor antagonists (montelukast), COPD drugs in development or targeting other pathways (roflumilast; polyvalent mechanical bacterial lysate; lipopolysaccharide), All other pharmaceutical interventions not treating COPD (enoxaparin sodium), Non-pharmaceutical interventions such as pulmonary rehabilitation.
- Studies that only compare treatments that are not of interest; studies that only include the treatments of interest in combination with treatments not of interest (i.e. prednisolone + formoterol); studies that only include the partial combinations of treatments of interest (i.e. tiotropium+ ICS).
- Studies with only healthy subjects without COPD; studies with subjects who have reversible airway or obstructive lung disease; studies with only subjects with asthma; studies that include asthma and COPD subjects but do not report data for COPD subjects separately; studies with only subjects who have alpha-1-antitrypsin-definciency-realted COPD; studies that include only children; studies that include adults and children but do not report data for adults separately.
- Trials in non-Caucasian population e.g. Chinese, Japanese subjects (including non-Caucasian registries).
- For full-text selection: Studies in which none of the relevant outcomes are reported. Studies which report only the following outcomes without any outcomes of interest: mortality; bioactivity outcomes or biomarkers of inflammation; lung mucociliary clearance; arterial blood gases or degree of pulmonary hyper-inflation; plethysmography and oscillometry; nocturnal hypoxemia; quality of life in EuroQol and Outcomes reported at other time points.
Trial location(s)
No location data available.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2023-01-05
Actual study completion date
2023-01-05
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website